Alveolar Ridge Preservation With Cortico-cancellous Porcine Bone

NCT ID: NCT06970184

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2025-06-01

Brief Summary

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Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.

Detailed Description

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The primary aim of this study is to compare the histomorphometric characteristics of two different formulations of CCPB used for ARP, and the secondary aim is to evaluate and compare clinical and aesthetic outcomes of dental implants placed in augmented sites.

Patients requiring the extraction of an hopeless tooth followed by ARP and subsequent implant placement are considered potentially eligible for the study.

At T0, Tooth extractions are performed trying to reduce the surgical trauma as possible. ARP is performed with 2 different combinations of a cortico-cancellous porcine bone with a thermogel (50:50 ratio, hand-mixed or 80:20 ratio, pre-mixed).

After 4 months of healing, patients undergo a radiographic examination before implant placement.

A T1, Implant site preparation is carried out using a trephine bur (to remove a core biopsy of the bone) followed by conventional osteotomy drills, and bone-level implants are placed. Bone samples are analyzed to evaluate new bone formation, presence of residual graft particles and marrow spaces.

Three months after placement, all implants are rehabilitated with screw-retained prosthetic crowns (T2).

Follow up is scheduled 1 year after prosthetic loading (T3).

Conditions

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Alveolar Ridge Preservation Implant Therapy Tooth Extraction Site Healing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARP 50:50

Tooth extraction + ARP with collagenated porcine bone hand-mixed (ratio 50:50) with a thermogel

tooth extraction with alveolar ridge preservation

Intervention Type PROCEDURE

alveolar ridge preservation performed after tooth extraction

Implant placement

Intervention Type PROCEDURE

Implant placement

ARP 80:20

Tooth extraction + ARP with collagenated porcine bone pre-mixed (ratio 80:20) with a thermogel

tooth extraction with alveolar ridge preservation

Intervention Type PROCEDURE

alveolar ridge preservation performed after tooth extraction

Implant placement

Intervention Type PROCEDURE

Implant placement

Interventions

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tooth extraction with alveolar ridge preservation

alveolar ridge preservation performed after tooth extraction

Intervention Type PROCEDURE

Implant placement

Implant placement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 yo
* Needing tooth extraction followed by ARP and implant-prosthetic rehabilitation

Exclusion Criteria

* uncontrolled systemic diseases
* uncontrolled periodontitis
* undergoing previous or actual treatment with medications/radiations potentially impairing hard and soft tissues healing
* women during pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Antonio Barone

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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BONEISTO_ARP

Identifier Type: -

Identifier Source: org_study_id

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